Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CCH-aaes · 1 trial · 2 indications
An adverse event (AE) was any unfavorable or unintended change in body structure (signs), body function (symptoms), laboratory result, or worsening of a pre-existing condition associated temporally with the use of the study medication whether or not considered related to the study medication. TEAEs were defined as any AEs with a start date equal to or after the date of the first injection. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Serum samples were analyzed for ADAs. The percentage of participants who developed ADAs (seropositive results) during the Open-label Phase of the study are reported.
| Arm | Type | Description |
|---|---|---|
| CCH-aaes Treatment in Parent Studies (EN3835-302/303) | EXPERIMENTAL | Participants who received CCH-aaes treatment in EN3835-302/303 were followed for 180 days of observation with no treatment. Participants who were identified as received CCH-aaes in the parent studies following the 180-day Observation Phase and entered the Open-label Phase of the study. Participants in the Open-label Phase who qualified for, and opted for, retreatment were administered CCH-aaes up to 1.68 mg at 3 treatment sessions, at 21-day intervals. |
| Placebo Treatment in Parent Studies (EN3835-302/303) | OTHER | Participants who received placebo in the parent studies, were followed for 180 days of observation with no treatment. After Day 180, all participants who received placebo during the double-blind parent studies were discontinued. No treatment was administered. |
| Name | Type | Description |
|---|---|---|
| CCH-aaes | BIOLOGICAL | Administered to participants who qualified for, and opted for, retreatment. |
| Observation | OTHER | No treatment administered during 180 days of observation. |
Key Inclusion Criteria All Participants (Through Day 180): 1. Voluntarily sign and date an informed consent agreement 2. Have participated in and completed the double-blind Phase 3 study EN3835-302 or EN3835-303 3. Be willing to apply sunscreen to the buttocks before each exposure to the sun and/o...
CCH-aaes is an investigational monoclonal antibody being developed for the treatment of Edematous Fibrosclerotic Panniculopathy, commonly known as cellulite. It is intended for use in adult women with this condition. The drug is currently in Phase 3 clinical development.
CCH-aaes is being developed by BrainsWay Ltd., a company traded on the stock exchange under the ticker BWAY. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of cellulite.
CCH-aaes is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Edematous Fibrosclerotic Panniculopathy, or cellulite, in adult women.
CCH-aaes has been studied in one completed Phase 3 clinical trial with the identifier NCT03526549. This trial, titled 'Long-Term Study of EN3835 (CCH-aaes) in Edematous Fibrosclerotic Panniculopathy (Cellulite)', enrolled 483 female participants aged 18 years and older in the United States.
Yes, CCH-aaes is also known as EN3835. The clinical trial NCT03526549 refers to the drug as EN3835, and it is being studied for the treatment of Edematous Fibrosclerotic Panniculopathy, or cellulite.